Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
DESOGESTREL ETHINYLESTRADIOL DESOGESTREL ETHINYLESTRADIOL
Aspen Pharma Trading Limited
DESOGESTREL ETHINYLESTRADIOL DESOGESTREL ETHINYLESTRADIOL
25/40 and Microgram
Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER GRACIAL ® 25/40 AND 125/30 microgram Tablets DESOGESTREL ETHINYLESTRADIOL IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES (CHCS): • They are one of the most reliable reversible methods of contraception if used correctly. • They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks. • Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”). READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, or your pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What is Gracial and what is it used for? 1.1 Composition and type of Pill 1.2 Why use Gracial? 2. What you need to know before you use Gracial 2.1 When you should not use Gracial 2.2 When to take special care with Gracial 2.3 When should you contact your doctor 3 How to use Gracial 3.1 When and how to take the tablets 3.2 Starting your first pack of Gracial 3.3 If too many Gracial tablets are taken (overdose) 3.4 What to do if 3.5 If you want to stop taking Gracial 4. Possible side effects 5. How to store Gracial 6. Further information 6.1 What Gracial contains 6.2 What Gracial looks like and Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gracial 25/40 and 125/30 microgram Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each blue tablet contains 25 microgram desogestrel and 40 microgram ethinylestradiol. Each white tablet contains 125 microgram desogestrel and 30 microgram ethinylestradiol. Each tablet also contains approximately 85mg Lactose Monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. The tablets are round, flat with bevelled edges and 6mm in diameter. They are coded on one side “Organon” and an asterix “*” and the reverse side “TR” above “8” (white tablets or “TR” above “9” (blue tablets). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Contraception. The decision to prescribe Gracial should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Gracial compares with other CHCs (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration: oral use. Before starting Gracial®, a thorough general medical and gynaecological examination (including breasts and a cytological smear of the cervix as appropriate) should be carried out and the family medical history carefully noted. Disturbances of the clotting mechanisms should be ruled out if any members of the family have suffered from thromboembolic diseases (eg deep vein thrombosis, stroke, myocardial infarction) at a young age. Pregnancy must be excluded ideally by a pregnancy test. As a precaution, thorough examinations should be conducted at approximately six month intervals during the use of the tablets. HOW TO TAKE GRACIAL Tablets must be taken in the order directed on the package every day Prečítajte si celý dokument